6th Jan 2021 08:45
(Alliance News) - AstraZeneca PLC on Wednesday announced its drug Farxiga has been granted priority review in the US for the treatment of adult patients with chronic kidney disease.
The British-Swedish pharmaceutical company said the US Food & Drug Administration granted priority based on clinical evidence from its DAPA-CKD phase 3 trial, which showed that Farxiga "reduced the risk of the composite of worsening of renal function or risk of cardiovascular or renal death by 39%", in patients with stages two to four of chronic kidney disease.
"This decision brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the US. Farxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type-2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease," said Mene Pangalos, Executive Vice President at BioPharmaceuticals Research & Development.
Back in March, AstraZeneca said an independent data monitoring committee recommended the trial be stopped early, based on its overwhelming efficacy and in October, Farxiga received breakthrough therapy designation in the US for patients with chronic kidney disease with and without type-2 diabetes.
Shares in AstraZeneca were down 0.6% at 7,392.00 pence in London on Wednesday.
By Zoe Wickens; [email protected]
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